Violation Code: 2240
FDA Violation
Charge Code: COSMETIC
Violation Details
- Violation Code (ASC ID)
- 2240
- Charge Code
- COSMETIC
- Description
- The article is subject to refusal of admission pursuant Section 801(a)(3) in that The article appears to be an ingredient in a cosmetic product and may have been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.
- Legal Section
- 601(c), 801(a)(3); Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Zhejiang Pure Essential Cosmetic Co., Ltd. | Lanxi, CHINA | 4 |
| 2 | Molcan Corp | Richmond Hill, CANADA | 2 |
| 3 | Pphu Aroma Trend Piotr Draniak | Michalowice, POLAND | 2 |
| 4 | Shanghai Jin Xing Trading Co | Guangzhouguangzhou, CHINA | 2 |
| 5 | Xiamen Anneng Economic Development Company | Xiamen, CHINA | 1 |
| 6 | HEMAO COSMETICS HUIZHOU CO LTD | Huizhou, CHINA | 1 |
| 7 | Guangzhou QingMang Biotechnology Co., Ltd | Guangzhou, CHINA | 1 |
| 8 | Sensient Colors LLC | S Plainfield, UNITED STA | 1 |
| 9 | Shanghai Jahwa United Co., Ltd | Shanghai, CHINA | 1 |
| 10 | Zhejiang Yasili Cosmetics Co., Ltd. | Jinhua, CHINA | 1 |
| 11 | Grand Forum Holdings Ltd | Kwun Tong, HONG KONG | 1 |
| 12 | Radiantly Alive | Bali, INDONESIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/8/2025 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CH03 | |
| 12/8/2025 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CH03 | |
| 12/8/2025 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CH03 | |
| 11/17/2025 | WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) 53LF10 | |
| 8/25/2023 | MASCARA (EYE MAKEUP PREPARATIONS) 53CK06 | |
| 9/2/2020 | FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) 53GH02 | |
| 1/12/2018 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CH03 | |
| 7/2/2013 | OTHER COSMETIC RAW MATERIALS, N.E.C. 53PH99 | |
| 7/2/2013 | OTHER COSMETIC RAW MATERIALS, N.E.C. 53PH99 | |
| 7/2/2013 | OTHER COSMETIC RAW MATERIALS, N.E.C. 53PH99 | |
| 5/17/2012 | OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. 53JF99 | |
| 2/23/2011 | OTHER COSMETIC RAW MATERIALS, N.E.C. 53PH99 | Molcan CorpCANADA |
| 2/23/2011 | OTHER COSMETIC RAW MATERIALS, N.E.C. 53PH99 | Molcan CorpCANADA |
| 9/23/2010 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | Radiantly AliveINDONESIA |
| 6/10/2009 | OTHER COSMETIC RAW MATERIALS, N.E.C. 53PH99 | Sensient Colors LLCUNITED STA |
Frequently Asked Questions
What is FDA violation code 2240?
2240 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant Section 801(a)(3) in that The article appears to be an ingredient in a cosmetic product and may have been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.". This violation is based on 601(c), 801(a)(3); Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2240?
According to FDA Import Refusal data, there have been 18 import refusals issued for violation code 2240, affecting 12 unique firms.
When was the most recent refusal for violation 2240?
The most recent import refusal for violation 2240 was on December 8, 2025.
What products are commonly refused for violation 2240?
Products commonly refused under violation 2240 include: EYE SHADOW (EYE MAKEUP PREPARATIONS), WRINKLE SMOOTHING (SKIN CARE PREPARATIONS), MASCARA (EYE MAKEUP PREPARATIONS). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2240?
Violation code 2240 is based on 601(c), 801(a)(3); Adulteration of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.